1. Field of the Invention
The present invention relates to a device that can be inserted into a body through a natural orifice with an endoscope or other steerable guide member. The present invention may be used in conjunction with a suturing instrument to secure an applied suture to the tissue of a mammal, whether human or not, and whether or not alive.
2. State of the Art
Natural Orifice Translumenal Endoscopic Surgery (NOTES) involves passing surgical instruments in association with an endoscopic camera through a natural orifice, such as the mouth, vagina, or anus, to a desired organ. By avoiding major incisions through the skin, muscle, and nerves of the abdomen, patients may experience a quicker recovery with less pain and scarring while further reducing the post-operative risk of surgery.
In co-owned US Pub. No. 20090312775A1, an endoscopic suturing device suitable for use in a NOTES procedure is described. The device has a structure with a sufficiently small distal profile for delivery through a natural orifice, while providing a needle movable on an arm through a large opening and closing angle and which produces a large force upon the needle for piercing tissue to perform a surgical operation such as tissue approximation and suturing. A length of suture is permanently attached to the needle and forms stitches about tissue engaged at the distal end of the device as the needle is moved through the tissue and the distal end of the device is moved relative to the tissue. After one or more stitches have been formed in the tissue, the needle is released from the device and the free end of the suture is secured relative to the tissue. In accord with one manner of securing the free end of the suture, portions of the suture may be tied together about the tissue. In accord with another manner of securing the suture, a cinch element is advanced over the suture and cinches the tissue between the needle on one side of the tissue and the cinch on the other side of the tissue. The suture is then severed.
In addition to the cinch and cinch-applying instrument described in the above-referenced publication, other cinch instruments and deployable cinches are known. For example, referring to prior art FIG. 1, also known is a cinch applicator 10 for use in deploying the two parts 12, 14 of a cinch onto suture 16 in a NOTES procedure. The applicator 10 includes an elongate flexible tubular member 18, a hypotube 20 fixed to the distal end 22 of the flexible tubular member 18, a flexible shaft 24 extending through the tubular member 18 and the hypotube 20, and a proximal handle (not shown) for moving the shaft 24 longitudinally relative to the tubular member 18. The hypotube 20 defines a distal housing 26 and a proximal lateral window 28. A slidable plunger 30 provided with a guillotine 32 is provided within the hypotube 20, with the guillotine 32 fully proximal of the housing 26 and distal of the lateral window 28.
The two-part cinch includes a collar 12 and a plug 14 engageable within the collar. The collar 12 has a cylindrical outer shape that is retained in the distal housing 26 of the hypotube 20 with a simple dimpling mating structure. The collar 12 also includes a proximal inner lip 33, and an outer lip 34 seating at the distal end of the hypotube 20 and having a flat distal facing end 35. The plug 14 of the cinch is attached to the distal end of the flexible shaft 24. The plug 14 has an enlarged distal flange 36 corresponding in size and shape to the outer lip 34 on the collar 12. The plug 14 has an elongate tubular body 38 defining a throughbore 40 in which the flexible shaft 24 extends, and a proximal circumferential exterior groove 42. A distal portion of the shaft 24 has a bend 44 to facilitate retention within the throughbore 40. The distal end of the shaft 24 has a rounded bead 46 that sits at the flange 36 of the plug. The bend 44 and the bead 46 trap the flexible shaft relative to the plug.
In operation, from outside the patient, the proximal end of the suture 16 is thread through the collar 12 and hypotube 20 and out of the lateral window 28. Then the applicator 10 is advanced through an endoscope so that the elements of the cinch are provided adjacent the stitched tissue. When the handle is operated, the shaft 24 is retracted to draw the plug 14 into an interference fit within the collar 12, with the inner lip 33 of the collar positively engaging the outer groove 42 on the plug. The suture 16 is captured between the outer surface of the plug 14 and the inner surface of the collar 12 so that the cinch is secured to the suture. Upon further retraction of the shaft 24, the shaft is pulled such that the bend 44 and bead 46 of the shaft 24 are pulled all the way through the plug 14 until released therefrom, and drawn back into engagement with the plunger 30. As the shaft 24 is moved further proximally relative to the hypotube 20, movement of the shaft 24 causes the guillotine 32 to slide past the window 28 and sever the proximal portion of the suture 16 from the portion of the suture attached to the cinch. Once the suture 16 is severed, a jerking motion is applied to the applicator 10 to release the engagement formed by the dimpling structure between to the cinch 12, 14 and applicator 10.
The applicator and cinch are thereby together capable of effectively securing stitched suture to tissue.